Bimekizumab phase III data in hidradenitis suppurativa show clinically meaningful, deep and maintained response over 48 Weeks.- UCB

Data from the two studies showed that bimekizumab achieved statistically significant and consistent clinically meaningful improvements over placebo in the signs and symptoms of HS at week 16, which were maintained to week 48.± Clinical responses with bimekizumab were observed from the first dose with some patients achieving HiSCR50 at week four. These new data were presented at a late-breaking platform presentation at the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans, U.S., 17th-22nd March.

The two studies (n=505 in BE HEARD I; n=509 in BE HEARD II) evaluated two dose regimens of bimekizumab (320 mg every two weeks [Q2W] and 320 mg every four weeks [Q4W]) versus placebo over the 16-week initial and the 32-week maintenance treatment periods. Data presented at AAD 2023 show that : i. A significantly higher proportion of patients treated with bimekizumab (Q2W) achieved HiSCR50, the primary endpoint, at week 16 vs. placebo in BE HEARD I and BE HEARD II (47.8 percent vs. 28.7 percent [p=0.006] and 52.0 percent vs. 32.2 percent [p=0.003], respectively). ii. A greater proportion of patients treated with bimekizumab (Q4W) achieved HiSCR50 at week 16 than placebo in BE HEARD I and BE HEARD II, with statistical significance achieved in BE HEARD II (45.3 percent vs. 28.7 percent [p=0.030] and 53.8 percent vs. 32.2 percent [p=0.004], respectively). iii.Patients treated with bimekizumab achieved deep levels of clinical response with a greater proportion achieving HiSCR75, a key secondary endpoint, at week 16 than placebo, with statistical significance in BE HEARD II with both dose regimens and for Q2W in BE HEARD I. iv. Patients treated with bimekizumab experienced improved health-related quality of life (change from baseline in the dermatology life quality index) compared with placebo at week 16 (BE HEARD I and BE HEARD II, Q2W and Q4W). v.Clinical responses (HiSCR50 and HiSCR75) were maintained with continuous bimekizumab treatment – over 75 percent of patients achieved HiSCR50, and over 55 percent achieved HiSCR75 at week 48 (observed case analysis; BE HEARD I and BE HEARD II, Q2W and Q4W).

“Today, at the largest dermatology meeting of the year, we unveiled 48-week data from our Phase III bimekizumab program in hidradenitis suppurativa. Results from the Phase III program highlight the meaningful clinical outcomes achieved by targeting IL-17F in addition to IL-17A,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. “We are now focused on the next steps with global regulatory filings for bimekizumab in hidradenitis suppurativa planned for later this year.”

The primary endpoint in both studies was HiSCR50 at week 16. A key secondary endpoint was HiSCR75 at week 16. HiSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.

The safety profile of bimekizumab across BE HEARD I and BE HEARD II was consistent with previous studies with no new safety signals observed. The most common (frequency of greater than 5 percent) treatment emergent adverse events on bimekizumab over 16 weeks were hidradenitis (7.2 percent in BE HEARD I and 8.8 percent in BE HEARD II), oral candidiasis (4.4 percent in BE HEARD I and 6.7 percent in BE HEARD II), headache (7.0 percent in BE HEARD I and 5.8 in BE HEARD II) and diarrhea (7.0 percent in BE HEARD I and 5.3 percent in BE HEARD II).

UCB expects to submit global regulatory applications for bimekizumab in moderate to severe HS starting in Q3 2023.